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CTRI Number  CTRI/2012/12/003261 [Registered on: 26/12/2012] Trial Registered Retrospectively
Last Modified On: 16/07/2013
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study   open label cross-over study 
Study Design  Other 
Public Title of Study   Bioequivalence of two levothyroxine tablet formulations in healthy Indian voulnteers 
Scientific Title of Study   Bioequivalence of two levothyroxine tablet formulations in healthy Indian Volunteeers: A single-dose randomiZed, open label, cross over study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
116517  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudershan Vishwanath 
Designation  Principal Investigator 
Affiliation   
Address  VIMTA Labs 142, IDA, Phase II,Cherlapally Hyderabad.

Hyderabad
ANDHRA PRADESH
500051
India 
Phone  04027264141  
Fax  04027263657  
Email  Vishwanath.Sudershan@vimta.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sadhna Joglekar 
Designation  Executive Vice President, Medical and Clinical operations & Medical Director 
Affiliation   
Address  GlaxoSmithKline Pharmaceuticals, 252, GSK House, Dr Annie Besant Road, Worli, Mumbai

Mumbai
MAHARASHTRA
400030
India 
Phone  02224959405  
Fax    
Email  sadhna.j.joglekar@gsk.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeroze Dalal 
Designation  General Manager, Clinical Operations 
Affiliation   
Address  GlaxoSmithKline Pharmaceuticals, 252, GSK House, Dr Annie Besant Road, Worli, Mumbai

Mumbai
MAHARASHTRA
400030
India 
Phone  02224959395  
Fax    
Email  jeroze.j.dalal@gsk.com  
 
Source of Monetary or Material Support  
GlaxosmithKline Pharmaceuticals Ltd 252, GSK House, Dr Annie Besant Roadm Worli, Mumbai_400 030 
 
Primary Sponsor  
Name  GlaxoSmithKline Pharmaceuticals Ltd 
Address  GlaxoSmithKline Pharmaceuticals, 252, GSK House, Dr Annie Besant Road, Worli, Mumbai 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudershan Vishwanath  Vimta Labs Ltd.  142,IDA Phase II, Cherlapally ,Hyderabad-500 051
Hyderabad
ANDHRA PRADESH 		 040-27264141

vishwanath.sudershan@vimta.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Samkshema Independent Ethics Committee,Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hypothyroidism 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Levothryroxine ( Reference Formulation)  Dose:600mcg Route:Oral Duration: Single Dose 
Intervention  Levothyroxine test formulation  Dose:600mcg Route:Oral Duration: Single Dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, 12 lead ECG and chest-x-ray. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Medical Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with total T4 (4.5 -12.0 µg/dL), T3 (0.79 - 1.49 ng/mL) and TSH (21 weeks - 20 years: 0.7 - 6.4 µIU/mL, 21 - 54 years: 0.4 - 4.2 µIU/mL) values outside the normal range should always be excluded from enrollment (Interpath Lab Instructions, 2010).
2.Males between 18 and 50 years of age (both inclusive), who are willing to participate in the study and provide a written signed and dated informed consent.
3.Body weight of 60 kg and BMI within the range 18.5-24.9 kg/m2 (inclusive).
4.Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
 
 
ExclusionCriteria 
Details  1.A positive pre-study urine drug screen.
2.A positive test for HIV antibody.
3.Subject has clinically significant abnormal values of laboratory parameters.
4.Regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units. One unit is equivalent to 8 g of alcohol: a half-pint ( approximate 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits (CTRI, 2010).
5.The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
6.Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
7.Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety.
8.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
9.Where participation in another study would result in donation of blood or blood products in excess of 350 ml within a 90 day period prior to this study.
10.Unwillingness or inability to follow the procedures outlined in the protocol.
11.Subject is mentally or legally incapacitated or the subject is incapable of understanding the informed consent.
12.Subject has any evidence of impaired renal, hepatic, cardiac, lung or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
13.History of sensitivity to heparin or heparin-induced thrombocytopenia.
14.Regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
15.Subject is intolerant to venipuncture.
16.Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To investigate the bioavailability of the test formulation of Eltroxin relative to the reference formulation of Eltroxin in euthyroid, healthy Indian volunteers  76 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of the test and the reference formulations of Eltroxin on serum TSH level in euthyroid, healthy Indian volunteers.To compare the relative safety of the test and the reference formulations of Eltroxin in euthyroid, healthy Indian volunteers.
 		 76 days 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/01/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="16" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Levothyroxine (T4) is the active ingredient present in Eltroxin tablets. Its physiologically active metabolite is tri-iodothyronine (T3). Levothyroxine is also endogenously produced in the body. Eltroxin is used to treat patients with hypothyroidism and may often result in lifelong therapy. Since small changes in levothyroxine administration (e.g. change in brand or formulation) can cause significant changes in serum thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is critical to avoid potential adverse iatrogenic effects. Till date, the active pharmaceutical ingredient (API) for Eltroxin tablets marketed in India has been sourced from Sandoz, Austria. GSK India proposes to change the source of the API from Sandoz to Peptido, Germany. In view of this change in the source of API, it is essential to determine whether it has any impact on drug product performance based on pharmacokinetic (PK) measures of total serum T4 and total serum T3 of the to-be-marketed formulation of Eltroxin (test formulation) relative to the formulation currently in the market (reference formulation). This will be a single-center, open-label, two-period, two-treatment, two-sequence, randomized, single-dose, crossover study in 26 healthy adult volunteers to assess the bioequivalence of the test formulation of Eltroxin to reference formulation of Eltroxin. The primary PK endpoints will be Cmax and AUC (0-48) after adjustment by baseline levels of endogenous T4. The secondary PK endpoints will include Cmax and AUC (0-48) (without adjustment by baseline levels of endogenous T4), Tmax , Kel  and t1/2 (with and without adjustment by baseline levels of endogenous T4) and serum TSH.  Safety endpoints will include vital signs, ECG, physical examination, clinical laboratory tests and AE reporting.

 
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